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AGARIC Case Control Study (AGARIC)

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ClinicalTrials.gov Identifier: NCT01966081
Recruitment Status : Unknown
Verified October 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : October 21, 2013
Last Update Posted : October 21, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:
The aim of the study is to establish the existence of a relationship between the dietary intake of polyunsaturated fatty acids (PUFA) and the risk of colorectal cancer in humans, using 2 reliable and complementary biomarkers: the fatty acid-composition of lipids of the abdominal subcutaneous adipose tissue and the fatty acid composition of erythrocyte phospholipids.

Condition or disease Intervention/treatment Phase
First Recently-diagnosed Colorectal Cancer Other: Blood sample Other: tissue samples from abdominal subcutaneous adipose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 576 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Consumption of Fatty Acids, Metabolism of Adipose Tissue and Risk of Colorectal Cancer: AGARIC Case Control Study
Estimated Primary Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cases Other: Blood sample
Other: tissue samples from abdominal subcutaneous adipose
controls Other: Blood sample
Other: tissue samples from abdominal subcutaneous adipose



Primary Outcome Measures :
  1. Measure of polyunsaturated fatty acids in adipose tissue lipids. [ Time Frame: baselines ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

CASES

  • Patients aged ≥ 45 years
  • with a first recently-diagnosed colorectal cancer
  • due to undergo elective surgical resection with curative intent (in practice, stage I, II, III or IV if there was only one hepatic nodule that was resected with curative intent) in one of the 5 following digestive surgery units: CHU de Dijon, CHU de Nancy, CHU de Strasbourg, CHU de Reims et CHU and Besançon.
  • who have given their informed consent

CONTROLS

  • Patients aged ≥ 45 years
  • due to undergo surgery for a benign abdominal disease (sigmoid diverticulitis, appendectomy, hiatal hernia …)
  • matched for abdominal site with cases for age (± 3 years), sex and hospital
  • Who have given their informed consent

Exclusion Criteria:

CASES

  • pre-operative anticancer treatment (chemo or radiotherapy)
  • existence of visceral metastases except a single hepatic nodule resected with curative intent
  • familial adenomatous polyposis and HNPCC syndrome (when suspected: inclusion after complementary tumor phenotype study: screening for microsatellite instability and/or immunohistochemistry study of the expression of DNA mismatch repair proteins.
  • known inflammatory disease of the intestine (ulcerative colitis, Crohn's disease)
  • personal history (recent or not) of colorectal cancer
  • emergency treatment for the presenting complication (perforation, occlusion…)
  • significant modification in dietary habits during the previous three months
  • other evolving neoplastic disease
  • psychic state incompatible with understanding the modalities and the aims of the study (notably patients under guardianship)
  • pregnant or breast-feeding women

CONTROLS

  • personal history of cancer or adenomatous colorectal polyps,
  • emergency intervention
  • known inflammatory disease of the intestine (ulcerative colitis, Crohn's disease)
  • personal history (recent or not) of colorectal cancer
  • emergency treatment for the presenting complication (perforation, occlusion…)
  • significant modification in dietary habits during the previous three months
  • evolving neoplastic disease
  • psychic state incompatible with understanding the modalities and the aims of the study (notably patients under guardianship)
  • pregnant or breast-feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966081


Contacts
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Contact: Claire BONITHON-KOPP 3 80 39 33 37 ext 33 bonithon@u-bourgogne.fr

Locations
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France
CHU Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Georges MANTION    3 81 66 82 43 ext 33      
CHU Dijon Recruiting
Dijon, France, 21079
Contact: Patrick RAT    3 80 29 37 47 ext 33    Patrick.rat@chu-dijon.fr   
Hôpital Robert Debré Recruiting
Reims, France, 51092
Contact: Jean-François DELATTRE    3 26 78 70 79 ext 33      
Hôpital Hautepierre Recruiting
Strasbourg, France, 67200
Contact: Serge ROHR    3 88 12 72 36 ext 33      
Hôpital de BRABOIS Recruiting
Vandoeuvre-les-nancy, France, 54511
Contact: Laurent BRESLER    3 83 15 31 20 ext 33      
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01966081     History of Changes
Other Study ID Numbers: Bonithon hors AOI 2008
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases